Derived from chitin obtained from Arctic shrimp shells, Synoplex® has an approximate molecular weight of 20 to 100 kDa. Each gram of Synoplex® contains 1 gram of poly (acetyl, arginyl) glucosamine. Synoplex® is supplied as a dry soluble powder, that is rehydrated with sterile water prior to use. Synoplex® acts on the bacterial membrane causing aggregation of bacteria and pore formation leading to reduction of viable bacteria and prevention of biofilm formation.

For topical application on animals in the family Elephantidae and Rhinocerotidae for treatment of foot and dermal lesions infected with aerobic or facultative anaerobic Gram-positive and/or Gram-negative bacteria; and for treatment of sterile chronic foot and dermal lesions.

﻿FOR USE IN ANIMALS IN THE FAMILY ELEPHANTIDAE AND RHINOCEROTIDAE ONLY; THIS PRODUCT IS NOT TO BE USED IN ANIMALS INTENDED FOR USE AS FOOD FOR HUMANS OR OTHER ANIMALS.

Not for use in humans. Keep out of the reach of children. In case of skin, eye contact, or ingestion, flush affected area with water. If inhalation occurs and breathing becomes difficult, move to fresh air, and contact a physician.

Poly (acetyl) glucosamine can be characterized as biologically safe, nontoxic, biocompatible and biodegradable polysaccharide. The publicly available toxicology and safety data adequately support the safety of poly (acetyl) glucosamine in terms of general toxicity in animals and in vitro and local tolerance studies. A series of general toxicology tests were also conducted to provide additional assurance that poly (acetyl, arginyl) glucosamine did not show differences from the safety profile of poly (acetyl) glucosamine. The results from these studies in rodents showed no test article-related changes in hematology or clinical chemistry, and no microscopic lesions associated with administration of poly (acetyl, arginyl) glucosamine. in a L5178Y TK +/- mouse lymphoma forward mutation screen, poly (acetyl, arginyl) glucosamine was also negative for induction of mutagenic activity after treatment for 4 hours with and without S9, and for 24 hours without S9.

Synoplex® is supplied as a dry soluble powder, needing to be rehydrated with sterile water prior to use. Wear gloves during handling and use of Synoplex®. Determine the amount of Synoplex® powder needed to achieve the desired concentration for the intended use. Dissolve Synoplex® in a known volume of sterile water and mix well. Before applying rinse treatment, ensure that the lesion is properly debrided.

A general dose of Synoplex® for infected wounds is 500μg/mL and for non-infected wounds is 200μg/mL in a volume sufficient to moisten the affected area. The frequency of application should be 1-2 times per day until the lesion is resolved. Synoplex® should always be used in conjunction with good wound care consisting of initial debridement to remove all necrotic and/or infected tissue.

Synoplex® is supplied as a dry soluble powder in amber glass bottles containing 1-gram of poly (acetyl, arginyl) glucosamine. Synoplex® is packaged in cartons containing either one (1) bottle or five (5) bottles of 1-gram of poly (acetyl, arginyl) glucosamine.

Number of versions: 2

RxNorm

Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.

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